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Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases.

RECRUITINGPhase 1Sponsored by Yi Tian
Actively Recruiting
PhasePhase 1
SponsorYi Tian
Started2025-09-11
Est. completion2027-07-30
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

Summary

A new radiotracer, 68Ga-FXX489 (NNS309), has been developed for tracking fibroblast activation protein (FAP) and visualizing the tumor stroma. The purpose of the study is to explore the diagnostic value of 68Ga-FXX489 (NNS309) PET/CT imaging in oncological diseases, to assess its safety, imaging characteristics, and biodistribution after administration.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Patients with a high suspicion of oncological diseases.
2. Age: 18-80 years, no gender restriction, able to express themselves independently, and willing to participate in this study with a signed informed consent form.

Exclusion Criteria:

1. Failure to sign the informed consent form.
2. Severe visual or auditory impairment, cognitive disorders, or patients with claustrophobia who cannot communicate effectively.
3. Severe cardiac dysfunction, cardiac function class III-IV.
4. Renal failure (serum creatinine level \> 1.2 mg/dl).
5. Allergy to alcohol.
6. Use of drugs within 1 week prior to the examination that can cause a disulfiram-like reaction with alcohol, such as penicillins, cephalosporins, or cefotetan.
7. Known pregnancy.

Conditions3

CancerMetastatic CancerTumor

Interventions2

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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